Fluconazole Capsule 50 mg (Fluconazole)

Adult dosage

The route of administration should be determined according to the patient's clinical condition. Oral formulations are absorbed rapidly and almost completely; therefore, the doses of oral formulations (capsules, dry syrup) and injectable formulations are the same. ○ Adults 1. Vaginal candidiasis: Administer 150 mg of fluconazole orally as a single dose. 2. Mucosal candidiasis 1) Oropharyngeal candidiasis: The usual dose is 50 mg of this drug once daily for 7-14 days; treatment may be extended at the physician's discretion. 2) Chronic atrophic oral candidiasis (oral pain due to dentures): The usual dose is 50 mg of this drug once daily for 14 days, and local disinfection of the dentures should be performed concomitantly. 3) Other mucosal candidiasis (esophageal candidiasis, noninvasive bronchopulmonary infections, candiduria, mucocutaneous candidiasis, etc., excluding vaginal candidiasis): The usual dose is 50 mg of this drug once daily for 14-30 days. For refractory mucosal candidiasis, the dose may be increased to 100 mg once daily. 3. Systemic candidiasis, including candidemia, disseminated candidiasis, and other invasive Candida infections (peritoneal, endocardial, pulmonary, urinary tract, etc.): The usual dose is 400 mg of this drug as a single dose on the first day, followed by 200 mg once daily from the next day; the dose may be increased to 400 mg once daily depending on the patient's response. The duration of treatment should be determined according to the clinical response and medical judgment. 4. Cryptococcal meningitis and cryptococcosis at other sites: The usual dose is 400 mg of this drug as a single dose on the first day, followed by 200-400 mg once daily from the next day. The duration of treatment is determined by the clinical and mycological response, but treatment should generally be given for at least 6 ~ 8 weeks. 5. To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 200 mg of this drug once daily indefinitely after the patient has completed all initial treatment. 6. Prevention of fungal infections in immunocompromised patients at risk of fungal infections due to neutropenia caused by cytotoxic chemotherapy, radiation therapy, or bone marrow transplantation: Administer 50-400 mg of this drug once daily, depending on the patient's degree of risk for fungal infection. A dose of 400 mg once daily is recommended for patients at very high risk of systemic fungal infection, such as those with severe neutropenia or an anticipated prolonged period of neutropenia, as in the case of bone marrow transplantation. In such patients, 400 mg should be administered starting 5-6 days before the expected onset of neutropenia and continued for 1 week after the neutrophil count has increased to 1,000 cells/mm3 or more. 7. For onychomycosis of the fingernails or toenails, administer 150 mg once weekly until the fingernail or toenail has regrown (until a new, uninfected fingernail or toenail has grown). It usually takes 3-6 months for a new fingernail to grow and 6-12 months for a toenail; growth rates may vary among individuals according to age. In some cases, the fingernails or toenails may remain damaged after successful treatment with long-term administration. Skin fungal infections, including athlete's foot (tinea pedis), tinea corporis, jock itch (tinea cruris), and cutaneous candidiasis: The usual dose is 50 mg of this drug once daily or 150 mg once weekly for 2-4 weeks. However, athlete's foot may require treatment for 6 weeks depending on the course of the infection. For tinea versicolor, administer 50 mg once daily for 2-4 weeks. ○ Older adults If renal function is normal, the usual adult dose may be administered. In patients with renal impairment (creatinine clearance 50 mL/min or less), the dose should be reduced or the dosing interval extended. ○ Patients with renal impairment This drug is excreted mainly in the urine unchanged. No dose adjustment is necessary when it is administered as a single dose. However, when multiple doses are required, administer the usual dose only on the first day of treatment and adjust the dose from the next day as follows. Creatinine clearance (mL/min) > 50: 100 % of the usual dose Creatinine clearance (mL/min) ≤50 (not on dialysis): 50% of the usual dose Patients on hemodialysis: 100% of the usual dose after each hemodialysis session Patients on hemodialysis should receive 100% of the usual dose after each hemodialysis session. On days when dialysis is not performed, the dose should be reduced according to creatinine clearance.

Children's dosage

○ Children Pediatric doses based on the adult dose are generally determined according to the following criteria and should not exceed 400 mg. Adult dose 100 mg: Pediatric dose 3 mg/kg Adult dose 200 mg: Pediatric dose 6 mg/kg Adult dose 400 mg: Pediatric dose 12 mg/kg However, the safety and efficacy in infants younger than 6 months have not been established (see Precautions for Use). 1. Oropharyngeal candidiasis: Administer 6 mg/kg of this drug on the first day, followed by 3 mg/kg once daily from the next day. Administer for at least 2 weeks to prevent recurrence. 2. Esophageal candidiasis: Administer 6 mg/kg of this drug on the first day, followed by 3 mg/kg once daily from the next day. The dose may be increased to 12 mg/kg once daily according to the patient's response. Administer for at least 3 weeks and for at least 2 weeks after symptoms resolve. 3. Systemic candidiasis, including candidemia, disseminated candidiasis, and other invasive Candida infections (peritoneal, endocardial, pulmonary, urinary tract, etc.): Administer 6-12 mg/kg once daily. The duration of administration is determined based on clinical response and medical judgment. 4. Cryptococcal meningitis: Administer 12 mg/kg of this drug on the first day, followed by 6 mg/kg once daily from the next day. The dose may be increased to 12 mg/kg once daily according to the patient's response. Continue treatment for 10-12 weeks after cerebrospinal fluid cultures become negative. 5. To prevent recurrence of cryptococcal meningitis in patients with AIDS, administer 6 mg/kg once daily after the patient has completed all primary treatment. 6. In children with renal impairment, extend the dosing interval and reduce the dose according to the same criteria as for adults with renal impairment. When administering doses of less than 10 mg, administer the syrup orally according to the child's clinical condition, or administer the injection intravenously, to ensure accurate dosing.

This medication should not be administered to certain patients. For example, patients with an allergic reaction to this drug or similar medications, pregnant women or women who may become pregnant, and nursing mothers should not use this medication. Additionally, patients taking certain medications should consult their physician or pharmacist as using this drug with them may pose a risk. For example, it should not be co-administered with drugs that can affect heart rhythm or certain antibiotics and antihistamines. Because this medication contains lactose, patients with lactose intolerance or certain genetic metabolic disorders should not take this medication. Patients with kidney or liver function issues should use this medication cautiously, and patients with heart disease or electrolyte abnormalities should use it cautiously due to the risk of side effects such as arrhythmia. This medication generally has good tolerance, but rarely, various side effects including blood disorders, liver function abnormalities, skin rashes, and heart-related issues may arise; thus, patients should immediately notify their healthcare provider of any abnormal symptoms. Patients with severe illnesses or AIDS should undergo regular blood, liver, and kidney function tests during treatment with this medication, and if liver enzyme levels significantly increase, the risks and benefits of treatment should be carefully evaluated. This medication can interact with various drugs, so if other medications are being taken, patients must inform their healthcare provider, and dosage adjustment or additional monitoring may be necessary during co-administration. Pregnant women should avoid using this medication, and women of childbearing potential should ensure effective contraception during treatment and for a certain period thereafter. Nursing mothers should also refrain from taking this medication. The safety in infants under 6 months of age has not been established; hence it should only be administered with caution when absolutely necessary. This medication can cause dizziness or seizures while driving or operating machinery, so caution is advised during these activities. In case of overdose, hallucinations or behavioral changes may occur, and prompt medical treatment is required. This drug is mainly excreted through urine; therefore, increasing fluid intake and possibly assisting elimination through hemodialysis may be required.

Agranulocytosis, leukopenia, neutropenia, thrombocytopenia, anaphylaxis, angioedema, hypertriglyceridemia, hypercholesterolemia, hypokalemia, insomnia, drowsiness, headache, seizures, dizziness, paresthesia, taste disturbance, tremor, vertigo, Torsade de pointes, QT prolongation, abdominal pain, diarrhea, nausea, vomiting, dyspepsia, bloating, dry mouth, increased ALT, increased AST, increased serum alkaline phosphatase, cholestasis, jaundice, increased bilirubin, hepatotoxicity, hepatic failure, hepatocyte necrosis, hepatitis, hepatocyte damage, rash, itching, urticaria, increased sweating, drug rash, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, exfoliative dermatitis, facial edema, hair loss, drug reactions with eosinophilia and systemic symptoms, myalgia, fatigue, lethargy, weakness, fever, adrenal insufficiency, hallucination, paranoid behavior

This medication should be stored in a tightly closed container to protect it from air and moisture. It is advisable to avoid direct sunlight and store it at room temperature.

Appearance

This medication is a hard capsule with a white powder inside, teal-green on the upper half and light yellow on the lower half.

Package unit

30 capsules/bottle, 100 capsules/bottle